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A kind of rupatadine fumarate tablet

A technology of rupatadine fumarate and tablets, which is applied in the directions of pill delivery, medical preparations of inactive ingredients, organic active ingredients, etc., to achieve good effects, ensure bioavailability, and improve the effect of loose tablets

Active Publication Date: 2015-09-23
海思科制药(眉山)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Clinically used antiallergic drugs have only antihistamine activity, but no PAF antagonism

Method used

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  • A kind of rupatadine fumarate tablet
  • A kind of rupatadine fumarate tablet
  • A kind of rupatadine fumarate tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] The preparation of embodiment 1-tablet of the present invention

[0029] prescription:

[0030]

[0031] Preparation method:

[0032] 1. Pass rupatadine fumarate through a 100-mesh sieve, and pulverize lactose, pregelatinized starch, and hydroxypropyl cellulose through a 80-mesh sieve for later use;

[0033] 2. Take Povidone K 30 , add an appropriate amount of 85% ethanol to dissolve, and make a 10% solution for later use;

[0034] 3. Mix red iron oxide and yellow iron oxide, and mix them with appropriate amount of lactose in equal increments, then add rupatadine fumarate, pregelatinized starch, hydroxypropyl cellulose and remaining lactose, mix evenly, add 10 % povidone K 30 Appropriate amount of 85% ethanol solution is made into soft material, granulated with 20 mesh sieve, dried at 50°C-70°C, moisture is controlled at 1.0%-3.0%, and granulated with 20 mesh sieve;

[0035] 4. Add magnesium stearate and talcum powder and mix evenly, measure the particle c...

Embodiment 2

[0039] The preparation of embodiment 2-tablet of the present invention

[0040] prescription:

[0041]

[0042] Preparation method:

[0043] 1. Pass rupatadine fumarate through a 100-mesh sieve, and pulverize lactose, pregelatinized starch, and hydroxypropyl cellulose through a 80-mesh sieve for later use;

[0044] 2. Take Povidone K 30 , add an appropriate amount of 85% ethanol to dissolve, and make a 10% solution for later use;

[0045] 3. Mix red iron oxide and yellow iron oxide, and mix them with appropriate amount of lactose in equal increments, then add rupatadine fumarate, pregelatinized starch, hydroxypropyl cellulose and remaining lactose, mix evenly, add 10 % povidone K 30 Appropriate amount of 85% ethanol solution is made into soft material, granulated with 20 mesh sieve, dried at 50°C-70°C, moisture is controlled at 1.0%-3.0%, and granulated with 20 mesh sieve;

[0046] 4. Add magnesium stearate and talcum powder and mix evenly, measure the particle conten...

Embodiment 3

[0050] Embodiment 3-preparation of tablet of the present invention

[0051] prescription:

[0052]

[0053] Preparation method:

[0054] 1. Pass rupatadine fumarate through a 100-mesh sieve, and pulverize lactose, pregelatinized starch, and hydroxypropyl cellulose through a 80-mesh sieve for later use;

[0055] 2. Take Povidone K 30 , add an appropriate amount of 85% ethanol to dissolve, and make a 10% solution for later use;

[0056] 3. Mix red iron oxide and yellow iron oxide, and mix them with appropriate amount of lactose in equal increments, then add rupatadine fumarate, pregelatinized starch, hydroxypropyl cellulose and remaining lactose, mix evenly, add 10 % Povidone K 30 Appropriate amount of 85% ethanol solution is made into soft material, granulated with 20 mesh sieve, dried at 50°C-70°C, moisture is controlled at 1.0%-3.0%, and granulated with 20 mesh sieve;

[0057] 4. Add magnesium stearate and stearic acid and mix evenly, measure the particle content, an...

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Abstract

The invention provides a rupatadine fumarate tablet. Each 1000 tablets comprise 12.8g of rupatadine fumarate, 30-120g of lactose, 3-15g of pregelatinized starch, 3-15g pf hydroxypropylcellulose, 0.03-0.30g of ferric oxide and 0.3-12g of wetting agent. According to the embodiment of the invention, looseness and color change and the like can be improved, and indissolvable main medicine is dissolved quickly, so that the in vivo bioavailability is ensured, and furthermore, good effect in clinical use is obtained.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a rupatadine fumarate tablet and a preparation method thereof. Background technique [0002] Allergic disease is a complex multifactorial disease. With the control of infectious diseases and the improvement of industrialization, it shows a trend of increasing year by year all over the world. The results of the epidemiological survey of allergic diseases in 30 countries published by the World Allergy Organization show that 22% (250 million people) of the total population of 1.2 billion in these countries suffer from various allergic diseases, such as anaphylaxis. Rhinitis, asthma, urticaria, eczema, etc. [0003] As far as the current clinical treatment of allergic rhinitis and allergic urticaria in my country is concerned, there are mainly antihistamines chlorpheniramine (chlorpheniramine), astemizole (astemizole), and terfenadine (allergic urtica...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/4545A61K47/38A61P37/08
Inventor 郑伟
Owner 海思科制药(眉山)有限公司
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